Observational Study of Acalabrutinib in Patients With Chronic Lymphocytic Leukaemia in the United Kingdom

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-130
SponsorAstraZeneca

About this trial

This is a retrospective observational research study to describe the characteristics and real-world clinical outcomes of patients with chronic lymphocytic leukaemia receiving acalabrutinib in the United Kingdom (the EPIC study). Physicians treating chronic lymphocytic leukaemia patients with acalabrutinib, where the patients started treatment as part of the acalabrutinib Early Access Programme (EAP), will be invited to recruit patients. Clinical data will be extracted from the patients' clinical records in line with local laws. Data from this study will provide UK-specific real-world data on patients who were started on acalabrutinib as part of the UK acalabrutinib EAP.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Treatment-naïve CLL patients who were initiated on acalabrutinib as part of the UK Early Access Programme

Received their first dose of acalabrutinib between 1 April 2020 and 1 April 2021

Patients aged ≥18 years old

Note: patients later found to have small lymphocytic lymphoma (SLL) may also be included in the EAP.

Disqualifiers

None

Trial population

Treatment-naïve adults (≥18 years old) with chronic lymphocytic lymphoma (CLL) who were initiated on acalabrutinib as part of the UK acalabrutiinib early access programme and received their first dose of acalabrutinib between 1 April 2020 and 1 April 2021.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Acalabrutinib

    Drug

    Acalabrutinib

Treatment groups

287 Participants
are divided into 1 treatment group
Group A: Group 11 intervention

Trial outcomes

Primary outcomes

1

Real-world progression free survival (rwPFS)

rwPFS will be defined as the time from index date until earliest record of real-world progression event as determined by physicians' assessment, or death (if no progression) or end of follow-up (for censored observations) whilst on first line treatment.

Time frame
12 months
2

Real-world progression free survival (rwPFS)

rwPFS will be defined as the time from index date until earliest record of real-world progression event as determined by physicians' assessment, or death (if no progression) or end of follow-up (for censored observations) whilst on first line treatment.

Time frame
24 months
3

Real-world progression free survival (rwPFS)

rwPFS will be defined as the time from index date until earliest record of real-world progression event as determined by physicians' assessment, or death (if no progression) or end of follow-up (for censored observations) whilst on first line treatment.

Time frame
36 months
4

Real-world progression free survival (rwPFS)

rwPFS will be defined as the time from index date until earliest record of real-world progression event as determined by physicians' assessment, or death (if no progression) or end of follow-up (for censored observations) whilst on first line treatment.

Time frame
48 months

Secondary outcomes

1

Real-world overall survival (rwOS)

rwOS will be defined as the time from index date up to death or last date the patient was known to be alive (for censored observations).

Time frame
12 months
2

Real-world overall survival (rwOS)

rwOS will be defined as the time from index date up to death or last date the patient was known to be alive (for censored observations).

Time frame
24 months
3

Real-world overall survival (rwOS)

rwOS will be defined as the time from index date up to death or last date the patient was known to be alive (for censored observations).

Time frame
36 months
4

Real-world overall survival (rwOS)

rwOS will be defined as the time from index date up to death or last date the patient was known to be alive (for censored observations).

Time frame
48 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

UKCLL Forum

Collaborator